Phase
Condition
Cutaneous Lupus Erythematosus
Musculoskeletal Diseases
Lupus
Treatment
Placebo
Ianalumab
Clinical Study ID
Ages 12-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Signed informed consent prior to participation in the extension study. Parent orlegal guardian's signed informed consent and child's assent, if appropriate, arerequired before any assessment is performed for participants <18 years of age. Ofnote, if the participant reaches age of consent (age as per local law) during thestudy, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
Participants must have participated in either one of the two SIRIUS-SLE corestudies, CVAY736F12301 or CVAY736F12302, and have completed the treatment periodthrough Week 60 without treatment discontinuation.
In the judgement of the investigator, participants must be expected to clinicallybenefit from continued study treatment.
Exclusion
Key Exclusion Criteria:
Use of prohibited therapies.
Active viral, bacterial or other infections requiring intravenous or intramusculartreatment for clinically significant infection which in the opinion of theinvestigator will place the participant at risk for participation.
Plans for administration of live vaccines during the study period.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, refusing or unable to use highly effective methods ofcontraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).
United States (and other countries, if locally required): sexually active males,unless they agree to use barrier protection during intercourse with women ofchild-bearing potential while taking study treatment.
Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires C1015ABO
ArgentinaActive - Recruiting
Novartis Investigative Site
San Miguel, Buenos Aires 1663
ArgentinaActive - Recruiting
Novartis Investigative Site
San Miguel de Tucuman, Tucuman T4000CBC
ArgentinaActive - Recruiting
Novartis Investigative Site
Tucuman, 4000
ArgentinaActive - Recruiting
Novartis Investigative Site
Maroochydore, Queensland 4558
AustraliaActive - Recruiting
Novartis Investigative Site
Salvador, BA 40150 150
BrazilActive - Recruiting
Novartis Investigative Site
Barretos, Sao Paulo 14784 400
BrazilActive - Recruiting
Novartis Investigative Site
Plovdiv, 4002
BulgariaActive - Recruiting
Novartis Investigative Site
Rimouski, Quebec G5L 5T1
CanadaActive - Recruiting
Novartis Investigative Site
Guangzhou, Guangdong 510080
ChinaActive - Recruiting
Novartis Investigative Site
Shantou, Guangdong 515041
ChinaActive - Recruiting
Novartis Investigative Site
Nanchang, Jiangxi 330006
ChinaActive - Recruiting
Novartis Investigative Site
Pingxiang, Jiangxi 337000
ChinaActive - Recruiting
Novartis Investigative Site
Chang Chun, Jilin 130021
ChinaActive - Recruiting
Novartis Investigative Site
Linyi, Shandong 276000
ChinaActive - Recruiting
Novartis Investigative Site
Urumqi, Xinjiang 830001
ChinaActive - Recruiting
Novartis Investigative Site
Beijing, 100069
ChinaActive - Recruiting
Novartis Investigative Site
Shanghai, 200127
ChinaActive - Recruiting
Novartis Investigative Site
Zhejiang, 315016
ChinaActive - Recruiting
Novartis Investigative Site
Medellin, Antioquia 050001
ColombiaSite Not Available
Novartis Investigative Site
Barranquilla, Atlantico 080020
ColombiaActive - Recruiting
Novartis Investigative Site
Chia, Cundinamarca 250001
ColombiaActive - Recruiting
Novartis Investigative Site
Bogota, 111611
ColombiaActive - Recruiting
Novartis Investigative Site
Brno, 63800
CzechiaActive - Recruiting
Novartis Investigative Site
Uherske Hradiste, 686 01
CzechiaActive - Recruiting
Novartis Investigative Site
Montpellier 5, 34295
FranceActive - Recruiting
Novartis Investigative Site
Montpellier Cedex 5, 34295
FranceSite Not Available
Novartis Investigative Site
Paris, 75014
FranceActive - Recruiting
Novartis Investigative Site
Leipzig, Sachsen 04103
GermanyActive - Recruiting
Novartis Investigative Site
Guatemala, 01010
GuatemalaActive - Recruiting
Novartis Investigative Site
Guatemala City, 01010
GuatemalaActive - Recruiting
Novartis Investigative Site
Szekesfehervar, Fejer 8000
HungaryActive - Recruiting
Novartis Investigative Site
Ahmedabad, Gujarat 380006
IndiaActive - Recruiting
Novartis Investigative Site
Ramat Gan, 5265601
IsraelActive - Recruiting
Novartis Investigative Site
Nagoya, Aichi 457 8510
JapanActive - Recruiting
Novartis Investigative Site
Sapporo city, Hokkaido 060 8648
JapanActive - Recruiting
Novartis Investigative Site
Seoul, Seocho Gu 06591
Korea, Republic ofActive - Recruiting
Novartis Investigative Site
Ipoh, Perak 30450
MalaysiaActive - Recruiting
Novartis Investigative Site
Ciudad de Mexico, Distrito Federal 06700
MexicoActive - Recruiting
Novartis Investigative Site
Leon, Guanajuato 37160
MexicoActive - Recruiting
Novartis Investigative Site
Guadalajara, Jalisco 44160
MexicoActive - Recruiting
Novartis Investigative Site
Merida, Yucatan 97070
MexicoActive - Recruiting
Novartis Investigative Site
Mexico, 07760
MexicoActive - Recruiting
Novartis Investigative Site
Wroclaw, Dolnoslaskie 52-210
PolandActive - Recruiting
Novartis Investigative Site
Bydgoszcz, 85-065
PolandActive - Recruiting
Novartis Investigative Site
Bytom, 41 902
PolandActive - Recruiting
Novartis Investigative Site
Warszawa, 00-874
PolandActive - Recruiting
Novartis Investigative Site
Braga, 4710243
PortugalActive - Recruiting
Novartis Investigative Site
Brasov, 500283
RomaniaActive - Recruiting
Novartis Investigative Site
Cluj Napoca, 400006
RomaniaActive - Recruiting
Novartis Investigative Site
Elche, Alicante 03203
SpainSite Not Available
Novartis Investigative Site
Santander, Cantabria 39008
SpainActive - Recruiting
Novartis Investigative Site
Badalona, Catalunya 08916
SpainActive - Recruiting
Novartis Investigative Site
Barcelona, Catalunya 08003
SpainActive - Recruiting
Novartis Investigative Site
Santiago De Compostela, Galicia 15706
SpainActive - Recruiting
Novartis Investigative Site
Madrid, 28034
SpainActive - Recruiting
Novartis Investigative Site
Taichung, 40447
TaiwanActive - Recruiting
Novartis Investigative Site
Taoyuan, 33305
TaiwanActive - Recruiting
Novartis Investigative Site
Bangkok, 10400
ThailandActive - Recruiting
Pinnacle Research Group Llc
Anniston, Alabama 36207
United StatesActive - Recruiting
Pinnacle Research Group Llc .
Anniston, Alabama 36207
United StatesActive - Recruiting
Advanced Medical Research
La Palma, California 90623
United StatesActive - Recruiting
Millennium Clinical Trials
Westlake Village, California 91361
United StatesActive - Recruiting
Clinical Res Of W Florida
Clearwater, Florida 33765
United StatesActive - Recruiting
Clinical Res. of W Florida
Clearwater, Florida 33765
United StatesActive - Recruiting
Accurate Clinical Research
Lake Charles, Louisiana 70601
United StatesActive - Recruiting
Ahmed Arif Medical Research Center
Grand Blanc, Michigan 48439
United StatesActive - Recruiting
West Tennessee Research Institute
Jackson, Tennessee 38305
United StatesActive - Recruiting
Shelby Research LLC
Memphis, Tennessee 38119
United StatesActive - Recruiting
Novel Research LLC
Bellaire, Texas 77401
United StatesActive - Recruiting
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